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The utility of radiological upper gastrointestinal series and clinical indicators in detecting leaks after laparoscopic sleeve gastrectomy: a case-controlled study

Sethi, Monica; Magrath, Melissa; Somoza, Eduardo; Parikh, Manish; Saunders, John; Ude-Welcome, Aku; Schwack, Bradley; Kurian, Marina; Fielding, George; Ren-Fielding, Christine
BACKGROUND: Leak after laparoscopic sleeve gastrectomy (LSG) often presents after hospital discharge, making timely diagnosis difficult. This study evaluates the utility of radiological upper gastrointestinal (UGI) series and clinical indicators in detecting leak after LSG. METHODS: A retrospective case-controlled study of 1762 patients who underwent LSG from 2006 to 2014 was performed. All patients with radiographically confirmed leaks were included. Controls consisted of patients who underwent LSG without leak, selected using a 10:1 case-match. Data included baseline patient characteristics, surgical characteristics, and UGI series results. Clinical indicators including vital signs, SIRS criteria, and pain score were compared between patients who developed leak and controls. RESULTS: Of 1762 LSG operations, 20 (1.1 %) patients developed leaks and were compared with 200 case-matched controls. Three patients developed leak during their index admission [mean = 1.3 days, range (1, 2)], while the majority (n = 17) were discharged and developed symptoms at a mean of 17.1 days [range (4, 63)] postoperatively. Patients diagnosed with leak were similar to controls in baseline and surgical characteristics. Contrast extravasation on routine postoperative UGI identified two patients with early leaks, but was negative in the remainder (89 %). Patients with both early and delayed leaks demonstrated significant clinical abnormalities at the time of leak presentation, prior to confirmatory radiographic study. In multiple regression analysis, independent clinical factors associated with leak included fever [OR 16.6, 95 % CI (4.04, 68.10), p < 0.0001], SIRS criteria [OR 7.0, 95 % CI (1.47, 33.26), p = 0.014], and pain score >/=9 [OR 19.1, 95 % CI (1.38, 263.87), p = 0.028]. CONCLUSIONS: Contrast extravasation on routine postoperative radiological UGI series may detect early leaks after LSG, but the vast majority of leaks demonstrate normal results and present 2-3 weeks after discharge. Therefore, clinical indicators (specifically fever, SIRS criteria, and pain score) are the most useful factors to raise concern for leaks prior to confirmatory radiographic study and may be used as criteria to selectively obtain UGI studies after LSG.
PMID: 26416376
ISSN: 1432-2218
CID: 1789772

The utility of esophagram and clinical indicators in detecting leaks after laparoscopic sleeve gastrectomy [Meeting Abstract]

Sethi, M; Magrath, M; Somoza, E; Parikh, M S; Saunders, J K; Ude-Welcome, A O; Schwack, B; Kurian, M; Fielding, G; Ren-Fielding, C
Aims: Leaks after laparoscopic sleeve gastrectomy (LSG) often present after discharge from the hospital, making it difficult to diagnose leak in the early postoperative period. This study evaluates preoperative, intraoperative, and postoperative factors in their association with leaks after LSG. Methods: A retrospective case-controlled study of 1762 LSG from 2006-2014 was performed. All radiographically confirmed leaks were included. Controls were patients who underwent LSG without leak, selected using a 10:1 (control:study) case-match. Data included patient characteristics, intraoperative factors, and esophagram results. Clinical indicators including SIRS criteria (presence of = 2: temperature<36 degreeC or >38 degreeC, heart rate>90 bpm, respiratory rate>20 breaths/min,WBC>12,000 or <4,000) and self-reported pain score were collected on postoperative day (POD) 2 and at the time of leak, if applicable. Statistics included univariate analyses and multivariate logistic regression. Results: Of the 1762 LSG, 20 (1.1 %) leaks were compared with 200 case-matched controls. Three patients developed leak during their index admission (mean = 1.3 days, range = [1,2]), while the majority (n = 17) were discharged and developed symptoms at a mean of 17.1 days (median = 15, range = [4,63]) postoperatively. Leaks were similar to controls in baseline characteristics; however, the leak group had fewer black patients (5 % vs. 17 %, p = 0.022). There were no differences in intraoperative characteristics including staple reinforcement, bougie size, leak test, or operativetime between groups. Contrast extravasation on routine postoperative esophagram was seen in only two (10 %) of the twenty patients with enteric leaks; other esophagram findings (e.g. delay, dilatation) did not differ between leaks and controls. Patients with both early and late leaks demonstrated significant clinical abnormalities at the time of leak presentation, prior to confirmatory radiographic study. In multiple regression analysis, independent factors associated with leak included fever (p<0.0001), SIRS criteria (p = 0.0034), and pain score = 9 (p = 0.010). Conclusions: Contrast extravasation on routine postoperative esophagram may detect early leaks after LSG, but the vast majority of leaks have normal results and present days to weeks after discharge. Therefore, clinical indicators (specifically fever, SIRS criteria, and pain score) are the most useful factors to raise concern for leaks prior to confirmatory radiographic study, and may be used as criteria to selectively obtain postoperative esophagrams after LSG
EMBASE:72209643
ISSN: 0930-2794
CID: 2049642

Intraoperative leak testing has no correlation with leak after laparoscopic sleeve gastrectomy

Sethi, Monica; Zagzag, Jonathan; Patel, Karan; Magrath, Melissa; Somoza, Eduardo; Parikh, Manish S; Saunders, John K; Ude-Welcome, Aku; Schwack, Bradley F; Kurian, Marina S; Fielding, George A; Ren-Fielding, Christine J
BACKGROUND: Staple line leak is a serious complication of sleeve gastrectomy. Intraoperative methylene blue and air leak tests are routinely used to evaluate for leak; however, the utility of these tests is controversial. We hypothesize that the practice of routine intraoperative leak testing is unnecessary during sleeve gastrectomy. METHODS: A retrospective cohort study was designed using a prospectively collected database of seven bariatric surgeons from two institutions. All patients who underwent sleeve gastrectomy from March 2012 to November 2014 were included. The performance of intraoperative leak testing and the type of test (air or methylene blue) were based on surgeon preference. Data obtained included BMI, demographics, comorbidity, presence of intraoperative leak test, result of test, and type of test. The primary outcome was leak rate between the leak test (LT) and no leak test (NLT) groups. SAS version 9.4 was used for univariate and multivariate analyses. RESULTS: A total of 1550 sleeve gastrectomies were included; most were laparoscopic (99.8 %), except for one converted and two open cases. Routine intraoperative leak tests were performed in 1329 (85.7 %) cases, while 221 (14.3 %) did not have LTs. Of the 1329 cases with LTs, there were no positive intraoperative results. Fifteen (1 %) patients developed leaks, with no difference in leak rate between the LT and NLT groups (1 vs. 1 %, p = 0.999). After adjusting for baseline differences between the groups with a propensity analysis, the observed lack of association between leak and intraoperative leak test remained. In this cohort, leaks presented at a mean of 17.3 days postoperatively (range 1-67 days). Two patients with staple line leaks underwent repeat intraoperative leak testing at leak presentation, and the tests remained negative. CONCLUSION: Intraoperative leak testing has no correlation with leak due to laparoscopic sleeve gastrectomy and is not predictive of the later development of staple line leak.
PMID: 26092015
ISSN: 1432-2218
CID: 1631142

Insurance-mandated medical weight management before bariatric surgery

Horwitz, Daniel; Saunders, John K; Ude-Welcome, Akuezunkpa; Parikh, Manish
BACKGROUND: Many insurance companies require a medical weight management (MWM) program as a prerequisite for approval for bariatric surgery. There is debate regarding the benefit of this requirement. The objective of this study is to assess the effect of insurance-mandated MWM programs on weight loss outcomes in our bariatric surgery population. OBJECTIVE: To assess the effect of insurance-mandated MWM programs on weight loss outcomes in our bariatric surgery population. SETTING: University. METHODS: A retrospective review of all bariatric surgery cases performed between 2009 and 2013 was conducted. Patients were stratified by payor mix based on whether the insurance company required MWM. To control for differences between groups, a bucket matching algorithm was used to match patients based on gender, age, body mass index (BMI), and surgery type (sleeve gastrectomy, gastric bypass, or gastric band). A repeated-measures regression model was created to estimate percent excess weight loss, percent excess BMI loss, and percent total weight loss. RESULTS: A total of 1432 bariatric surgery patients were reviewed. The bucket-matching algorithm resulted in 560 patients for final analysis. Mean age and BMI were 41 years and 43 kg/m2, respectively, and 91% were female. The regression model found no significant differences in weight loss outcomes between the MWM group and the comparison group at 1 year and 2 years-percent total weight loss: 21.3% [95% confidence interval [CI] 20.6%-22.1%] versus 20.2% [95%CI 19.7%-20.6%) at 1 year and 23.4% [95%CI 22.6%-24.3%] versus 21.5% [95%CI 21.0%-22.0%] at 2 years. CONCLUSION: There was no difference in weight loss outcomes up to 2 years in patients who required insurance-mandated MWM programs. Longer-term studies are needed to determine the benefit of this insurance requirement.
PMID: 26775043
ISSN: 1878-7533
CID: 1921902

Thirty-Day Readmission After Laparoscopic Sleeve Gastrectomy-a Predictable Event?

Sethi, Monica; Patel, Karan; Zagzag, Jonathan; Parikh, Manish; Saunders, John; Ude-Welcome, Aku; Somoza, Eduardo; Schwack, Bradley; Kurian, Marina; Fielding, George; Ren-Fielding, Christine
BACKGROUND: Thirty-day readmission post-bariatric surgery is used as a metric for surgical quality and patient care. We sought to examine factors driving 30-day readmissions after laparoscopic sleeve gastrectomy (LSG). METHODS: We reviewed 1257 LSG performed between March 2012 and June 2014. Readmitted and nonreadmitted patients were compared in their demographics, medical histories, and index hospitalizations. Multivariable regression was used to identify risk factors for readmission. RESULTS: Forty-five (3.6 %) patients required 30-day readmissions. Forty-seven percent were readmitted with malaise (emesis, dehydration, abdominal pain) and 42 % with technical complications (leak, bleed, mesenteric vein thrombosis). Factors independently associated with 30-day readmission include index admission length of stay (LOS) >/=3 days (OR 2.54, CI = [1.19, 5.40]), intraoperative drain placement (OR 3.11, CI = [1.58, 6.13]), postoperative complications (OR 8.21, CI = [2.33, 28.97]), and pain at discharge (OR 8.49, CI = [2.37, 30.44]). Patients requiring 30-day readmissions were 72 times more likely to have additional readmissions by 6 months (OR 72.4, CI = [15.8, 330.5]). CONCLUSIONS: The 30-day readmission rate after LSG is 3.6 %, with near equal contributions from malaise and technical complications. LOS, postoperative complications, drain placement, and pain score can aid in identifying patients at increased risk for 30-day readmissions. Patients should be educated on postoperative hydration and pain management, so readmissions can be limited to technical complications requiring acute inpatient management.
PMID: 26487330
ISSN: 1873-4626
CID: 1810502

1000 consecutive sleeve gastrectomies in an urban safety-net hospital: Accreditation facilitated safe expansion of surgical services [Meeting Abstract]

Parikh, M; Horwitz, D; Saunders, J; Welcome, A U; Pachter, H L
Introduction: Laparoscopic sleeve gastrectomy (LSG) is currently the most common bariatric surgical procedure in the US. It is considered technically simpler to perform than the gastric bypass and is more effective than the gastric band. It is an ideal procedure to implement in an urban safety-net hospital with limited resources. There is also debate regarding "Center of Excellence (COE)" accreditation and potential decreased access to bariatric surgery for under-represented minorities. Methods: A retrospective chart review of the first 1000 LSG at our institution was performed. Our institution is a public hospital that primarily serves under-represented minorities. Patient demographics and surgical outcomes were collected. A repeated measures model was used to create a % excess weight loss (%EWL) model. Outcomes were also compared before vs. after COE accreditation. Results: The cohort was predominantly Hispanic and non-Hispanic African American (96%). The vast majority (>75%) were insured publicly or were uninsured (15%). Mean age and BMI were 39 years and 45 kg/m2, respectively. There was an eleven-fold increase in surgical volume after COE accreditation. 1 year %EWL was 64%. 30-day readmission and reoperation was 1.5% and 0.4%, respectively. Leak rate was 1.2%. There were no mortalities. Conclusions: The COE model facilitated safe expansion of LSG at an urban safety-net institution
EMBASE:72280378
ISSN: 1550-7289
CID: 2151112

Gastric band removal for device-related complications may be associated with significant morbidity [Meeting Abstract]

Horwitz, D; Saunders, J; Welcome, A U; Youn, H; Fielding, G; Ren-Fielding, C; Kurian, M; Schwack, B; Parikh, M
Intro: Laparoscopic adjustable gastric banding is well-known for its safety profile. However, band removal, especially for a device-related complication, may be more complex due to the scar tissue created by the band. The objective of this study is to review perioperative outcomes of patients requiring band removal for device-related complications. Methods: A retrospective review was conducted of all band removals over a 13 year period (2001-2014) for a device-related complication (e.g. slippage, erosion, gastric necrosis). Bands removed for weight loss failure or intolerance were excluded from this review. Perioperative complication, readmission and reoperation/re-intervention was defined according to the Metabolicand Bariatric Surgery Accreditation and Quality Improvement Program standards. Results: A total of 104 patients required band removal for a device-related complication. In the same time frame 7633 bands were implanted. The average age at band removal was 44 years old and the average BMI was 35.6. The most common reason was slip (42%) and erosion (28%). The 30-day complication rate from the removal was 26% (27/104) - most commonly pneumonia and perigastric abscess. The 30-day readmission rate and reoperation/ re-intervention rate were 15% and 10%, respectively. There was one mortality (1%) from septic shock secondary to erosion. There were no statistically significant differences in age (p = 0.452) or BMI (p = 0.523) between those who had a 30-daycomplication and those who did not. Conclusions: Band-related complications are rare. Band removal for device-related complication may be associated with significant morbidity
EMBASE:72280154
ISSN: 1550-7289
CID: 2151132

Pregnancy following bariatric surgery: The effect of time-to-conception on maternal weight gain and nutritional status [Meeting Abstract]

Yau, P; Chui, P; Parikh, M; Saunders, J; Zablocki, T; Welcome, A U
Background: At our medical center, female patients who have undergone bariatric surgery are advised to defer pregnancy for two years surgery, in an attempt to avoid the following complications: inadequate maternal weight gain (for pregnancy), inadequate maternal weight loss (following bariatric surgery), hyperemesis gravidarum, and nutritional deficiencies. Methods: We examined our database of bariatric surgery patients from a large, urban, public hospital from March 2011 to July 2013. During that period, we identified 54 women who became pregnant after undergoing bariatric surgery. Of these women, 41 were included in the analysis. Twenty-six pregnancies occurred in women who had undergone bariatric surgery less than 2 years prior to conception, and 15 occurred in women who had undergone bariatric surgery greater than 2 years prior to conception. Gestational age at delivery, number of NICU admissions, weight gain during pregnancy, hyperemesis gravidarum, and nutritional deficiencies (iron, vitamins, protein, glucose) during pregnancy were compared for the two groups. Results: The women with <2 years between bariatric surgery and conception had a higher percentage of RYGB and LSG surgeries (p=0.0003), and had more weight loss (p=0.018) and BMI loss (0.014) from bariatric surgery to conception. There were no significant differences in pregnancy outcomes when comparing mothers with <2 years and >2 years between bariatric surgery and conception. The rates of full-term deliveries (85% vs. 87%, P=0.321), NICU admissions (4% vs. 7%, P=0.999), hyperemesis gravidarum (31% s. 40%, P=0.548) were not significantly different between the two groups. There were also no significant differences in nutritional deficiences, including iron (58% vs. 60%, P=0.885), vitamin B1(46% vs. 20%, P=0.177), vitamin B6 (12% vs. 0%, P=0.287), vitamin B12 (31% vs. 13%, P=0.277) vitamin D (65% vs. 87%, P=0.168), protein (62% vs. 40%, P=0.183) and low blood glucose (77% vs. 73%, P=0.999). Conclusions: There were no significant differences in gestational age, rate of NICU admission, pregnancy weight gain, hyperemesis, or nutritional deficiencies when comparing women who conceived within 2 years or after 2 years of their bariatric surgery. (Table Presented)
EMBASE:72280129
ISSN: 1550-7289
CID: 2151142

Long-term follow-up of pilot randomized trial comparing bariatric surgery vs. intensive medical weight management on diabetes remission in patients with type 2 diabetes and BMI 30-35; the role of sRAGE diabetes biomarker as predictor of success [Meeting Abstract]

Horwitz, D; Chung, M; Sheth, S; Saunders, J; Welcome, A U; Schmidt, A M; Dunn, V; Pachter, H L; Parikh, M
Introduction: To provide longer-term follow-up of a previously published pilot randomized trial comparing bariatric surgery vs. intensive medical weight management (MWM) in patients with type 2 diabetes (T2DM) and BMI 30-35. Additionally, to assess whether the soluble form of RAGE (receptor for advanced glycation end-products) is an adequate diabetes biomarker that may help determine which patient population would benefit most from surgery. Methods: Originally, 57 patients with T2DM and BMI 30-35 were randomized to surgery (bypass, sleeve or band, based on patient preference; n=29) vs. MWM (n=28). The 6 month results showed that surgery was significantly effective (previously published data). We performed an updated review of this patient cohort to evaluate weight loss and diabetes remission at 2 years. A repeated measures linear model was created to compare the change in HbA1C and BMI between the two groups. The outcomes were also compared to baseline sRAGE status using a repeated measures linear model. Patients who ultimately crossed over from MWM to surgery group (after the initial study) were included. Results: At baseline, mean BMI was 32.6 and mean HbA1c was 7.8. At 2 years the following was noted: The surgery group continued to have significantly higher diabetes remission (50% vs. 0%), lower BMI (28.5 vs. 30.9; p<0.0001) and lower HbA1c (7.0 vs. 7.9; p=0.019) than the MWM group. In the surgical group, those with a higher baseline sRAGE had a lower post-op BMI (p=0.037). Conclusion: At 2 years, bariatric surgery was very effective in patients with T2DM and BMI 30-35. Higher baseline sRAGE predicted success with surgery. However, larger studies will be required to confirm the accuracy of these observations
EMBASE:72280047
ISSN: 1550-7289
CID: 2151172

Intraoperative leak testing has no correlation with leak after laparoscopic sleeve gastrectomy [Meeting Abstract]

Sethi, M; Zagzag, J; Patel, K; Magrath, M; Parikh, M S; Saunders, J K; Ude-Welcome, A O; Schwack, B F; Kurian, M S; Fielding, G A; Ren-Fielding, C J
Introduction: Staple line leak is the most feared complication after sleeve gastrectomy. Intraoperative methylene blue and air leak tests are routinely used to evaluate for leak, however the utility of these tests is controversial. The 2012 International Sleeve Gastrectomy Expert Panel failed to reach a consensus about whether routine intraoperative leak tests should be performed. Additionally, these tests are not benign - they introduce increased instrumentation, with reports of nasogastric tubes causing esophageal perforation, as well as increased costs in the form of resource utilization. We hypothesize that the practice of routine intraoperative leak testing is unnecessary during sleeve gastrectomy. Methods and Procedures: A retrospective cohort study was designed using a prospectively-collected database of seven bariatric surgeons from two institutions. 1,257 consecutive patients who underwent sleeve gastrectomies between March 2012 and June 2014 were included. The performance of intraoperative leak testing and the type of test (air or methylene blue) were based on surgeon preference. Data obtained included BMI, patient demographics, comorbidity, presence or absence of intraoperative leak test, result of leak test, and type of test. The primary outcome was leak rate between the leak test (LT) group and the non-leak test (NLT) group. SPSS-22 was used for univariate and multivariate analyses. Results: Of the 1,257 sleeve gastrectomy cases, most (99.68 %) were laparoscopic, except for two (0.16 %) open and two (0.16 %) converted cases. 1,164 (92.6 %) patients had routine intraoperative leak tests performed; there were no positive intraoperative leak tests in the entire cohort. 93 patients (7.4 %) did not have intraoperative leak tests performed. Thirteen (1 %) patients developed staple line leaks, with no difference in leak rate between the LT and NLT groups (1 % vs. 1.1 %, p = 1.000). There were some baseline differences between the groups, however (Table 1). After adjusting for these differences and other possible confounders with binary logistic regression, the observed lack of association between leak and intraoperative leak test remained. In this cohort, leaks presented at a mean of 11.3 days postoperatively (range = [1,35]), with only two leaks presenting during the index admission. Of those two, one patient with a leak seen on postoperative day 1 esophagram underwent a repeat leak test during diagnostic laparoscopy, which was negative. Despite suture reinforcement, the leak persisted and the patient eventually required conversion to gastric bypass. Conclusion: Intraoperative leak testing has no correlation with postoperative leak occurrence after laparoscopic sleeve gastrectomy and is not predictive of the later development of staple line leak. (Table Presented)
EMBASE:71871568
ISSN: 0930-2794
CID: 1601352